Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe
- Conditions
- Type 2 diabetes, diabetic kidney diseaseMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 21.1Level: LLTClassification code 10045250Term: Type II diabetes mellitus with renal manifestationsSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-001155-40-DK
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Main eligibility criteria for control group (cross-sectional study alone):
•No diabetes mellitus
•No kidney disease or urinary albumin creatinine ratio = 30mg/g
•No contraindication to examination by magnetic resonance
Main eligibility criteria for control group (cross-sectional study alone):
•Age 40-80 years
•No diabetes mellitus
•No kidney disease or urinary albumin creatinine ratio = 30mg/g
•No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone):
•Age 40-80 years
•Type 2 diabetes
•No kidney disease or urinary albumin creatinine ratio = 30mg/g
•No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial):
•Age 40-80 years
•Type 2 diabetes
•Estimated glomerular filtration rate =30ml/min/1,73m2
•Urinary albumin creatinine ratio = 30mg/g
•No contraindication to examination by magnetic resonance
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 40
Please refer to E.3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.<br>;Secondary Objective: To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease. ;Primary end point(s): Primary endpoint in intervention trial:<br>•Urinary albumin creatinine ratio<br><br>Primary endpoint in cross-sectional part of study:<br>•Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)<br><br>;Timepoint(s) of evaluation of this end point: For intervention trial: At baseline (randomization visit) and at end of treatment of 16 weeks<br><br>For cross-sectional part of study: At baseline
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: For intervention trial: At baseline (randomization visit) and at end of treatment of 16 weeks<br><br>For cross-sectional part of study: At baseline;Secondary end point(s): Secondary endpoints in intervention trial:<br>•Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)<br>•MR estimate (by Dixon’s method) of kidney parenchymal fat fraction<br><br>Secondary endpoints in cross-sectional part of study<br>•MR estimate (by Dixon’s method) of kidney parenchymal fat fraction<br>